BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2850787 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10918
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH SYMPTOMS OF 'ACUTE' PAIN AND JOLTING SENSATION IN 'L2 AND L5, DOWN THE LEGS, AND NUMBNESS IN HIS FEET.' THE SYMPTOMS WERE NOTED TO HAVE OCCURRED FOLLOWING A CAR ACCIDENT ON (B)(6) 2011. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN ABLE TO SEE A HEALTHCARE PROVIDER (HCP) SINCE HIS ACCIDENT TO HAVE HIS DEVICE CHECKED. IT WAS ALSO REPORTED PATIENT WAS HAVING COUPLING AND OR COMMUNICATION ISSUES AND HAD TRIED ADJUSTING AND REPOSITIONING ANTENNA AS WELL AS USING ANTENNA LOCATE IN THE PAST BUT CONTINUED TO HAVE 'DIFFICULTIES' GETTING FULL COUPLING. IT WAS NOTED THAT THE ABILITY TO GET GOOD COUPLING HAD DECREASED BY 80% SINCE PATIENT'S ACCIDENT. ADDITIONAL INFORMATION RECEIVED 5 DAYS LATER INDICATED IMPEDANCE TEST AND REPROGRAMMING WAS PERFORMED, RESULTS WERE NORMAL AND THE PATIENT DEPARTED WITH 'GOOD' STIMULATION. THERE WERE NO MALFUNCTIONS DETERMINED AND THE PATIENT WAS NOTED TO 'STRUGGLE' UNDERSTANDING CHARGING SYSTEM. NINE MONTHS LATER, IT WAS REPORTED THAT THE PATIENT 'NEVER' HAD THERAPEUTIC EFFECT AND THE 'SCS NEVER HELPED WITH HIS BACK PAIN.' IT WAS UNCLEAR IF THE PATIENT LOST THERAPY OR NEVER HAD THERAPY. THE PATIENT ALSO EXPERIENCED A SHOCKING SENSATION, AND IF HE MOVED 'A CERTAIN WAY, HE WOULD GET SHOCKED.' THE SHOCKS WERE NOTED TO BE PRESENT BEFORE AND AFTER PATIENT'S BACK CAR ACCIDENT. PATIENT 'WAS SICK OF GETTING SHOCKED' SO HE LET THE IMPLANTABLE NEUROSTIMULATOR (INS) RAN OUT, AND ONCE IT RAN OUT HE STOPPED GETTING SHOCKED. IT WAS NOTED THAT THE PATIENT WANTED HIS DEVICE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1